Status:
UNKNOWN
Endothelial Function Evaluation in Patients With PAOD Treated With Sulodexide + Conventional Treatment (CT) Vs CT Alone
Lead Sponsor:
Alfa Wassermann Tunisia
Collaborating Sponsors:
Poseidon CRO
Conditions:
Peripheral Arterial Obstructive Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
A randomized Multicentric open-label controlled trial. The primary objective of the study is to assess the improvement of endothelial function under sulodexide + conventional treatment or conventional...
Detailed Description
A randomized Multicentric open-label controlled trial. The primary objective of the study is to assess the improvement of endothelial function under sulodexide + conventional treatment (antiplatelet t...
Eligibility Criteria
Inclusion
- Intermittent claudication.
- A systolic ankle brachial index ABI \< 0. 9
- An age of over 40 years
- At least one cardiovascular risk factor (active or weaned Smoking, diabetes mellitus, hypertension, lipid disorders, obesity, and erectile dysfunction) or a history of coronary artery disease or transient ischemic stroke or established.
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
Exclusion
- withdrawal of informed consent
- participation in another clinical trial with investigational drugs within the last 12 weeks or during the present trial period
- history of hypersensitivity to the investigational/conventional drugs
- Non claudicating patients and patients with critical ischemia
- Arteritis of non-atherosclerotic origin
- Patients treated with the oxalate or Naftidrofuryl Pentoxifiline Cilostazol or within 3 months that preceded the inclusion
- Patients receiving other agents that alter the secretion of NO (such as Sildenafil and Tadalafil) less than 2 weeks before inclusion
- Patients receiving a regimen based on nitrates or molsidomine or Bosentan
- Patients receiving Anti Vitamin K medication (AVK)
- Hemorrhagic accident dating less than 15 days before inclusion
- Heparin treatment or any treatment by low molecular weight heparins during the study for a continuous period of more than 10 days or a cumulative time during the study for more than 21 days.
Key Trial Info
Start Date :
January 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2020
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT03370705
Start Date
January 31 2019
End Date
March 30 2020
Last Update
December 2 2019
Active Locations (3)
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1
InvSite Poseidon0031
Sfax, Tunisia, 3000
2
InvSite Poseidon 0022
Sousse, Tunisia, 4000
3
InvSite Poseidon0011
Tunis, Tunisia, 1006